Browse Drug Recalls
2,085 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,085 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 2,085 FDA drug recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 25, 2013 | Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Wobur... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Wob... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pha... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, W... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, W... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Wobu... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Wobu... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallim... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 25, 2013 | Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, W... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Pallimed Solutions |
| Mar 22, 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx onl... | Failed Tablet/Capsule Specifications: Broken tablets | Class II | Actavis Inc |
| Mar 22, 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-cou... | Failed Tablet/Capsule Specifications: Broken tablets | Class II | Watson Laboratories, Inc.-(Actavis) - Florida |
| Mar 22, 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablet... | Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour ... | Class III | Actavis South Atlantic LLC |
| Mar 21, 2013 | Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 6... | Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product'... | Class II | Precision Dose Inc. |
| Mar 20, 2013 | Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston ... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharma... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Methylcobalamin 12.5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Ba... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Vancomycin 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Ro... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Injection vehicle, 120 ml, Clinical Specialties Compounding Pharmacy, 318 Bas... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Methylcobalamin 1250 mcg/ml, Clinical Specialties Compounding Pharmacy, 318 ... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Ophthalmic dilation gel (MAR), Clinical Specialties Compounding Pharmacy, 318... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Bast... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Phenylephrine-cyclopentolate, Clinical Specialties Compounding Pharmacy, 318 ... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Sodium Chloride (23.4%), Clinical Specialties Compounding Pharmacy, 318 Basto... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Basto... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Mitomycin (modified) 0.02% solution, Clinical Specialties Compounding Pharmac... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Medroxyprogesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 ... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 B... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Test Cyp 25 mg-e(2) blend 12 mg/ml, Clinical Specialties Compounding Pharmacy... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Test Cyp 50 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharma... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Tetracaine(buffered) 0.25% solution, Clinical Specialties Compounding Pharmac... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 ... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 ... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Gentamicin buffered 36.4 mg/ml, Clinical Specialties Compounding Pharmacy, 31... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road,... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Medroxyprogesterone 150 mg/ml,Clinical Specialties Compounding Pharmacy, 318 ... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
| Mar 20, 2013 | Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy,... | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... | Class II | Clinical Specialties Compounding Pharmacy |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.